Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
coagulation factor VIII; Von Willebrand Factor
Pharmaniaga Marketing Sdn Bhd
coagulation factor VIII; Von Willebrand Factor
1vial Vials
OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES.M.B.H.
XXXXXXX-XX XXXXXXX-XX XXXXXXX-XX Mat-No./CAN/DataMatrix: XXXXXXX-XX (CODE IS A SAMPLE) / Version: 09 / 2020-09-28 / Product code: 189 / WILATE / MALAYSIA / 520 X 270 MM / BLACK / SATZSTUDIO BORNGRÄBER / font size: 9PT INSTRUCTION FOR USE (SUMMARY OF PRODUCT CHARACTERISTICS) 1 NAME OF THE MEDICINAL PRODUCT WILATE 500, 500 IU VWF/500 IU FVIII, powder and solvent for solution for injection WILATE 1000, 1000 IU VWF/1000 IU FVIII, powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Wilate is presented as a powder and solvent for solution for injection. Each vial contains nominally 500 IU/1000 IU human von Willebrand factor (VWF ) and human coagulation factor VIII (FVIII). The product contains approximately 100 IU/ml human von Willebrand factor when reconstituted with 5 ml/10 ml Water for Injections with 0.1 % Polysorbate 80. The specific activity of Wilate is ≥ 67 IU VWF:RCo/mg protein. The VWF potency (IU) is measured according to ristocetin cofactor activity (VWF:RCo) compared to the International Standard for von Willebrand Factor Concentrate (WHO). The product contains approximately 100 IU/ml human coagulation factor VIII when reconstituted with 5 ml/10 ml Water for Injections with 0.1% Polysorbate 80. The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Wilate is ≥ 67 IU FVIII:C/ mg protein. Produced from the plasma of human donors. Excipient(s) with known effect: Wilate 500: 11.7 mg sodium per ml reconstituted solution (58.7 mg sodium per vial). Wilate 1000: 11.7 mg sodium per ml reconstituted solution (117.3 mg per vial). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Freeze-dried powder: white or pale yellow powder or crumbly solid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Von Willebrand disease (VWD) Prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone Прочитайте повний документ